Remote Regulatory Project Manager — Biotech Submissions

Parexel; Helena (MT); Remote; USD 90,000 - 130,000; Full time

Job summary

Parexel is seeking experienced US-based Regulatory Project Managers for home-based roles. You will drive regulatory submissions, oversee project delivery, and contribute to strategic planning for biotech clients, acting as the main client contact and FDA liaison when required.

Ideal candidates bring a strong regulatory and project management background, leadership, and excellent stakeholder management, with a proactive, client-focused approach and readiness to adapt to client processes and time

Qualifications

• Bachelor's degree in a relevant scientific field; advanced degree preferred.
• Minimum 3+ years in a regulatory affairs project management role.
• Proven track record leading global regulatory projects and milestones.
• Knowledge of global regulatory requirements across therapies.
• Strategic thinking to translate regulatory insights into business opportunities.
• Strong multitasking in complex regulatory programs.
• Excellent communication and interpersonal skills across all levels.
• Leadership experience mentoring team members.
• Adaptable to changing regulatory environments and priorities.

Responsibilities

• Oversee the operational execution of diverse regulatory projects.
• Ensure timely delivery of high-quality regulatory submissions.
• Contribute to long-term strategic planning for clients' regulatory initiatives.
• Manage project scope and budget.
• Identify and mitigate risks while maintaining compliance.
• Collaborate closely with clients’ teams and internal stakeholders.
• Drive continuous improvement in regulatory processes and methodologies.
• Facilitate meetings as main client/internal contact and FDA liaison as needed.
• Build client relationships and pursue new and repeat business.

Skills

Regulatory affairs

Project management

Leadership

Stakeholder management

Communication

Client relations

Risk mitigation

Time management

Japanese

Education

Bachelor's degree in a scientific field

PharmD/PhD or equivalent preferred

Job description

Parexel is seeking experienced US-based Regulatory Project Managers for home-based roles. You will drive regulatory submissions, oversee project delivery, and contribute to strategic planning for biotech clients, acting as the main client contact and FDA liaison when required.

Ideal candidates bring a strong regulatory and project management background, leadership, and excellent stakeholder management, with a proactive, client-focused approach and readiness to adapt to client processes and time